Posted on February 2nd, 2015
by David Hansen
On January 14th, 2015, I delivered a corporate presentation at the BIOTECH Showcase in San Francisco, during which I was pleased to highlight MabVax’s accomplishments from a very productive 2014 and outline our plans for 2015. I would like to share those with you now.
Currently, we are building our Company around two complementary technology platforms that utilize the human immune system to generate diagnostic and therapeutic products to treat cancer. Our clinically advanced therapeutic vaccine program has two late stage Phase 2 clinical trials underway with licensed vaccines expecting overall survival results in 2016. Additionally, we have a third vaccine that has completed a very encouraging Phase 1 trial in patients with neuroblastoma and is expected to move into a Phase 2 trial late this year.
Very important to our success are two antibody based products also entering Phase 1 trials in late 2015. This antibody was discovered through the immune response of patients vaccinated in a Phase 1 trial with one of our vaccines licensed from Memorial Sloan Kettering Cancer Center (MSKCC); we are aiming to report out early safety and pharmacology results by year-end.
Following the lead antibody program is a robust pipeline of early stage antibody candidates targeting multiple solid tumor cancers that we plan to bring forward into preclinical development this year.
2014 was an extremely busy and, more importantly, productive year for the Company. Shortly after the mid-year merger between MabVax and Telik, we strengthened our board of directors with the addition of four new independent members with significant financial and public company experience. Our lead antibody candidate HuMab 5B1 entered clinical manufacturing in order to have the supplies for our planned Phase 1 trials this year. This same lead antibody program was awarded the second phase of a $1.75 million contract from the National Institutes of Health (NIH) to offset preclinical expenses for development of a next generation diagnostic agent for pancreatic cancer based on our lead antibody candidate HuMab 5B1 coupled to a radiolabel. We entered into agreements with both MSKCC and Juno Therapeutics on development of new CAR T-cell products to treat solid tumors. MabVax supplies the target binding sequences for the new products based on our antibody discoveries. We also received Orphan Drug Designation status from FDA for our therapeutic cancer vaccine to address the childhood cancer, neuroblastoma.
From a financial standpoint, we raised $7.5M in the first half of the year and completed our merger in July. Given the upcoming near term milestones and robust pipeline of antibody based products, we are ideally positioned as we move into 2015.
This year will hold significant opportunity for both investors and patients as we follow through on the business plan we put in place in 2014. We will be reporting on our progress as we move two antibody-based products into Phase 1 clinical trials near the end of the year. There will be important progress milestones regarding safety and toxicology results, manufacturing clinical materials, and clinical trial agreements during the year. We plan to expand our various agreements with academic and corporate partners during the year. We will be reporting on the neuroblastoma vaccine program as we work through the regulatory and clinical planning milestones in preparation for initiating a Phase 2 trial. We will also report on our efforts to bring follow-on antibodies through the early development program as well as our activities aimed at building our own antibody based drug conjugate pipeline. The Company will continue to pursue early out-licensing opportunities to monetize individual programs as they reach the proof-of-concept stage. We believe our approach to achieving revenues by out-licensing after de-risking the early development cycle is a good business model for us at this stage of the company. This model allows us to stay lean and minimize costs associated with larger studies while validating our technologies and programs while enhancing the value of the company for shareholders.
We believe MabVax is well positioned for 2015 with value inflection points anticipated in 12 to 18 months on four separate programs and look forward to reporting on key milestones throughout the year.
Forward Looking Statements
Certain statements contained in this blog are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this blog relate to, among other things, the offering and, expected use of proceeds from the offering. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this blog. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this blog, except as required by applicable law.